|Publication number||US7713392 B2|
|Application number||US 10/907,805|
|Publication date||May 11, 2010|
|Filing date||Apr 15, 2005|
|Priority date||Apr 15, 2005|
|Also published as||EP1920254A2, EP1920254A4, EP1920254B1, EP2752661A2, EP2752661A3, US20060231417, US20100308837, WO2006109275A2, WO2006109275A3|
|Publication number||10907805, 907805, US 7713392 B2, US 7713392B2, US-B2-7713392, US7713392 B2, US7713392B2|
|Inventors||Ian Harding, Sridhar Iyengar, Baoguo Wei, Steven Diamond, Martin Forest|
|Original Assignee||Agamatrix, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (15), Referenced by (6), Classifications (11), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The invention relates to a system for analyzing a sample using an electrochemical cell. The electrochemical cell is provided in a test strip. The test strip is elongated and has the cell at one end (sometimes called the “distal” end) and has a connection region at the other end (sometimes called the “proximal” end). The connector region is shaped to plug into a connector on an apparatus. The apparatus contains electronic circuitry for applying signals to the cell and for monitoring signals received from the cell.
The test strip is made up of layers. In an exemplary embodiment the layers are as described in U.S. patent application No. 60/521,555 filed May 21, 2004, which application is incorporated herein by reference for all purposes. An elongated substrate or carrier provides mechanical rigidity and support. Deposited or painted onto the substrate are conductive paths such as those shown in
Turning ahead to
The path 15 (not visible in
Exemplary methods and apparatus for such analysis are described in PCT publications WO 2005/022143, WO 03/069304, and WO 2003/060154, each of which is hereby incorporated herein by reference for all purposes.
It would be extremely desirable to devise features of a test strip which would permit testing of the strip to find out whether the conductive paths are being laid down correctly. One problem with many test strip designs is that testing of particular conductive paths risks damaging the paths. With such designs, the very act of testing poses a risk of making the strip less reliable. Destructive testing then leads to lower manufacturing yields. This is an undesirable state of affairs.
It would also be extremely desirable to devise features of a test strip and of the associated analytical apparatus which would permit defining particular test strips as having been made for use in particular geographic regions or for specific customers. Then, in a way which brings to mind the regional coding of DVDs (digital video disks) and DVD players, a strip made for use in a particular region or for a particular customer would work only with an apparatus made for use in that region.
Finally it would be desirable to have a structure of conductors that helps to control the printing of the reagent so that it deposits in the right place.
A test strip and analytical apparatus have pin connections permitting the definition of geographic regions or of particular customers. A test strip made for use in a particular region or for a particular customer will have pin connections matching features of the apparatus made for use in that region or by that customer. Insertion of the strip into the apparatus does not merely turn on the apparatus, but provides the regional or customer coding. Analog switches within the apparatus allow coding of a larger number of distinct regions or customers than would otherwise be possible, all without degrading the quality of the measurements made of the fluid being tested. Conductive paths in the strips permit testing the strips during manufacture so as to detect quality lapses regarding the printing or deposition of the paths.
The invention will be described with respect to a drawing in several figures.
For each of these configurations, particular pin assignments must be made. The pin assignments appear toward the top of
Toward the bottom of
The conductive path 13, for example, permits pressing probes into the path at 17 and 18 to test for defects in the Y direction. Probes can be pressed into positions 19 and 18 as well, which will test for defects in the X direction. Such tests may damage the path 13 but if they do, this does not interfere with or degrade the signals to and from the reaction cell.
If the path containing points 20 and 21 is not otherwise in use, then the test equipment could be used at those two points, again without degrading the signals to and from the reaction cell.
Returning briefly to
Stated differently, in one embodiment a planar test strip is elongated for a length along a first axis, the strip having an electrochemical analysis cell at one axial end and a connection region at the other axial end, the strip made up of at least a first layer. The first layer has deposited thereupon at least one conductor extending from the connection region to the electrochemical cell, the conductor having a first portion which is not a conductive path for analysis. The first portion extends along the axis for at least one-fifth of the length of the strip. First and second test probes may be applied to the first portion, the first and second test probes separated by at least one-fifth of the length of the strip.
Furthermore, the strip has a width, and the conductor has a second portion which is not a conductive path for analysis, the second portion extending perpendicular to the axis for at least one-fifth of the width of the strip. Third and fourth test probes may be applied to the second portion, the third and fourth test probes separated by at least one-fifth of the width of the strip. The third and fourth probes can be the same as the first and second probes, or can be different.
Omitted for clarity in
The jumpers in
It should be noted that the arrangement of
In the case of configuration 8, for example, the counter electrode is shared with the strip-detect 1 and ground detection signals.
Once the meter (analytical apparatus) has detected the strip, the meter breaks the shared connection by asserting “detection done” (line 24 in
It should be appreciated that in an exemplary embodiment, the meter does not merely detect a strip, but specifically detects which connector pins are connected (within the strip) to other connector pins. Furthermore, the meter even more specifically checks to make sure that pins which are not supposed to be connected to anything else (within the strip) are in fact not connected to anything else.
Stated differently, if a strip is inserted, the meter may detect it (will “wake up”), but then if the jumper configuration of the meter fails to match the within-the-strip connections, then the meter will not proceed with analysis but will instead annunciate the mismatch.
Thus, the meter checks not only that each pin that is supposed to be connected to some other pin is actually connected, but it also checks that any pin that is not supposed to be connected is actually not connected to anything else. The check may be termed an “if and only if” in the sense that the match is only satisfied if the correct pins are connected while the other pins that are not supposed to be connected are not connected.
In one embodiment, then, the meter determines whether predefined first and second pins of the strip are connected, defining a first finding, and determines whether a predefined third pin is not connected to either of the first and second pins, defining a second finding, and performs the analysis only in the event that the first and second findings are in the affirmative.
It will be further appreciated that it is possible to use varying resistance of various traces in the strip as a way of increasing the number of distinct strips that can be distinguished electrically.
The functionality described here is thus much more than a mere “strip detect” functionality.
Another aspect of the invention may be seen in connection with the reagent absorptive pad 12, which can be seen in
Thus in one embodiment there is a planar test strip elongated for a length along a first axis, the strip comprising at least first, second, and third planar layers, the second planar layer lying between the first and third planar layers, the strip having an electrochemical analysis cell at one axial end and a connection region at the other axial end, the first layer having deposited thereupon a first conductor extending from the connection region to the electrochemical cell, the first layer also having deposited thereupon a second conductor extending nearby to but not in conductive relationship to the first conductor, the strip further comprising an electrochemical reagent deposited upon the first layer, the reagent extending to lie atop a portion of the first conductor and extending to lie atop a portion of the second conductor, the second conductor not in conductive relationship to the connection region.
A method used with such a planar test strip comprises the steps of depositing upon the first layer a first conductor extending from the connection region to the electrochemical cell, depositing upon the first layer a second conductor extending nearby to but not in conductive relationship to the first conductor, the second conductor not in conductive relationship to the connection region; and depositing upon the first layer an electrochemical reagent, the reagent extending to lie atop a portion of the first conductor and extending to lie atop a portion of the second conductor.
Those skilled in the art will have no difficulty devising myriad obvious improvements and variations, all of which are intended to fall within the scope of the invention as defined by the claims that follow.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US5160278||Oct 22, 1990||Nov 3, 1992||Miles Inc.||Reagent strip calibration system|
|US20030116447||Oct 4, 2002||Jun 26, 2003||Surridge Nigel A.||Electrodes, methods, apparatuses comprising micro-electrode arrays|
|US20030146110||Feb 1, 2002||Aug 7, 2003||Karinka Shirdhara Alva||Electrochemical biosensor strip for analysis of liquid samples|
|US20030159945 *||Nov 30, 2001||Aug 28, 2003||Shoji Miyazaki||Biosensor, measuring instrument for biosensor, and method of quantifying substrate|
|US20030178322||Jan 15, 2003||Sep 25, 2003||Iyengar Sridhar G.||Method and apparatus for processing electrochemical signals|
|US20040045821 *||Apr 17, 2002||Mar 11, 2004||Gang Cui||Electrochemical biosensors|
|US20040086423||Oct 24, 2003||May 6, 2004||Wohlstadter Jacob N.||Multi-array, multi-specific electrochemiluminescence testing|
|US20040182703||Jan 26, 2004||Sep 23, 2004||Home Diagnostics, Inc.||Systems and methods for blood glucose sensing|
|US20050069892||Feb 10, 2003||Mar 31, 2005||Iyengar Sridhar G.||Method and apparatus for assay of electrochemical properties|
|US20050098433||Nov 6, 2003||May 12, 2005||3M Innovative Properties Company||Electrochemical sensor strip|
|US20050098434||Nov 6, 2003||May 12, 2005||Gundel Douglas B.||Electrode for electrochemical sensors|
|WO2001071328A1||Jan 27, 2001||Sep 27, 2001||All Medicus Co., Ltd.||Electrochemical biosensor test strip with recognition electrode and readout meter using this test strip|
|WO2003060154A2||Jan 15, 2003||Jul 24, 2003||Agamatrix, Inc.||Method and apparatus for processing electrochemical signals|
|WO2003069304A2||Feb 10, 2003||Aug 21, 2003||Agamatrix, Inc||Method and apparatus for assay of electrochemical properties|
|WO2005022143A2||Aug 23, 2004||Mar 10, 2005||Agamatrix, Inc.||Method and apparatus for assay of electrochemical properties|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8888973||Jul 29, 2011||Nov 18, 2014||Roche Diagnostics Operations, Inc.||Encoded biosensors and methods of manufacture and use thereof|
|US9176091||Sep 16, 2011||Nov 3, 2015||Agamatrix, Inc.||Method and apparatus for encoding test strips|
|US9267911||Nov 17, 2014||Feb 23, 2016||Roche Diabetes Care, Inc.||Encoded biosensors and methods of manufacture and use thereof|
|US9451908||Dec 19, 2012||Sep 27, 2016||Dexcom, Inc.||Analyte sensor|
|WO2012037486A1||Sep 16, 2011||Mar 22, 2012||Agamatrix, Inc.||Method and apparatus for encoding test strips|
|WO2014143495A1||Feb 14, 2014||Sep 18, 2014||Agamatrix, Inc.||Analyte detection meter and associated method of use|
|U.S. Classification||204/403.02, 204/403.04, 205/777.5, 204/403.01|
|Cooperative Classification||B01L2300/02, B01L3/545, B01L3/5023, G01N27/3272|
|European Classification||B01L3/545, G01N27/327B1|
|May 10, 2005||AS||Assignment|
Owner name: AGAMATRIX, INC., MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HARDING, IAN;IYENGAR, SRIDHAR;WEI, BAOGUO;AND OTHERS;REEL/FRAME:015990/0785;SIGNING DATES FROM 20050419 TO 20050504
Owner name: AGAMATRIX, INC.,MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HARDING, IAN;IYENGAR, SRIDHAR;WEI, BAOGUO;AND OTHERS;SIGNING DATES FROM 20050419 TO 20050504;REEL/FRAME:015990/0785
|Oct 10, 2013||FPAY||Fee payment|
Year of fee payment: 4
|Dec 30, 2015||AS||Assignment|
Owner name: MIDCAP FINANCIAL TRUST, MARYLAND
Free format text: SECURITY INTEREST;ASSIGNOR:AGAMATRIX, INC.;REEL/FRAME:037405/0728
Effective date: 20151223